Do you know the most significant changes under the new ISO 9001?

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ISO 9001

The ISO 176/SC committee is preparing a draft document in which they have made a number of changes and/or customisations to the current ISO 9001:2008, which we will summarize below.

The most significant changes

  • Scope and field of application

The continuous improvement reference has been eliminated and improvement is left

The reference is changed to the product and refers literally to goods and services

Various changes and additions are proposed in the section “Terminology”, which introduces new terms such as interested parties and risks.

Note: (These terms and definitions are manifested in the ISO 9000 planned for 2015)

  • Quality management system

It continues to focus on processes for management systems and delves into new aspects to contemplate the approach of system processes.

  • Management responsibility (now with the broader term of “Leadership”)

Deepen the commitment to address management, linking policy and quality objectives for the management and strategic policy of the company and the need to promote innovation

Establish that the planning system should aim to identify risks and opportunities in the business of the company and thus control them

  • Resources (Now with the broader term of “Support”)

More precisely establishes the field of competence of personnel.

This section contains the requirements on documented information on the system as an aspect of support

  • Product realization (now with broader title of “Operation” )

Establishes with much more information the controlling of the supply of goods and services and in particular external information and documents with external suppliers

The subsection of the current standard for design and development (product) is changed to the broader “Development of goods and services” to raise the necessary steps to be carried out according to each organization, good or service to ensure that, as necessary, their requirements and characteristics are planned in an early stage of development until the last of the after sales activity.

This point speaks of the non-conformities of goods and services (much more consistent than as at present, which is Nonconforming Product at the point of Measurement, Analysis and Improvement).

  • Measurement, analysis and improvement (now with the broader heading “Evaluation of organizational performance”).

Sets an initial preamble, which will take into account the risks and opportunities in determining what needs to be monitored and controlled in relation to the processes of the organization.

Aspects of measuring customer satisfaction and internal audits are maintained and this includes the Management System Review by the Department (in the current standard referred to in the point Management Responsibility)

A new and final Improved point is established (in the current standard it is a subsection of Measurement, analysis and improvement) and primarily and fundamentally in this improvement the following point is taken into account:

-The actions to correct non-conformities will take place only via Corrective Actions and preventive and treatment actions disappears, which are in the current standard

-The organization must improve compliance, adequacy and effectiveness of quality management systems (a need for improvement is put forth, eliminating the quote “continuous improvement” (if listed in the current standard)

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